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Trial registered on ANZCTR


Registration number
ACTRN12616001491459
Ethics application status
Approved
Date submitted
24/08/2016
Date registered
27/10/2016
Date last updated
27/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Ketamine in Acute Behavioural Disturbance
Scientific title
Ketamine in Acute Behavioural Disturbance: The Safety and Effectiveness of Ketamine for sedation of patients with acute behavioural disturbance during aeromedical retrieval
Secondary ID [1] 289995 0
None
Universal Trial Number (UTN)
U1111-1186-7805
Trial acronym
KIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Behavioural Disturbance 300003 0
Condition category
Condition code
Mental Health 299899 299899 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will be evaluating the use of intravenous ketamine to chemically restrain patients with acute behavioural disturbance during aeromedical retrieval. Participants will be followed up for upto 30 minutes post-handover to the recieving healthcare facility. All data will be colected by a restrospective chart audit of electronic databases at RFDS,Queensland and LifeFlight,Queensland.
Intervention code [1] 295698 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299381 0
Proportion of participants who were endotracheal intubated which will be assessed by a retrospective review of medical records at RFDS,Queensland and LifeFlight,Queensland.
Timepoint [1] 299381 0
At any point during aeromedical retrieval upto 30minutes after participant handover to the receiving healthcare facility
Secondary outcome [1] 326995 0
Proportion of participants who develop cardiovascular, respiratory or ketamine-specific adverse reactions which will be assessed by a retrospective review of medical records at RFDS,Queensland and LifeFlight,Queensland.
Timepoint [1] 326995 0
At any point during aeromedical retreival upto 30minutes after participant handover to the receiving healthcare facility

Eligibility
Key inclusion criteria
All participants with acute behavioural disturbance needing aeromedical retrieval between January 1,2015 and June 30,2016
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All participants who received ketamine for an indication other than chemical restraint i.e. analgesia and intubation

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Data abstraction will be done by study authors whilst adhering to standard chart review guidelines including abstractor training, explicit eligibility criteria, precise definition of variables, standardized abstraction forms, periodic meetings and performance monitoring. Interrater reliability will be tested by a blinded review of a random sample of 15% of the charts by the principal investigator and will be measured using the -statistic. The abstractors will not be blinded to the study hypothesis as they are co-investigators of this study and are closely involved in its design and conduct. The data will be abstracted from the patient records after de-identification using a standardized data abstraction form and procedures manual . Any data conflicts during data abstraction due to ambiguous, conflicting or erroneous data will be resolved by periodic meetings and consensus between the abstractors VG, ML, LB, KH, MW and AP.Missing data will be managed by imputation.
The collected data will be analyzed using SPSS 22.0 and descriptive and comparative statistics will be calculated. Continuous variables will be tested for normality. Based on the outcome of the test, parametric Student’s T test or non-parametric Mann-Whitney test will be carried out to determine the differences in data. Categorical data will be analyzed using the Chi-squared analysis. P-values and confidence intervals will be used to determine statistical significance. A p value < 0.05 and 95% confidence intervals that do not overlap unity will be considered statistically significant.

The investigators have not performed a formal sample size calculation due to the the difficulty in estimating the number of patients who could have received ketamine during the study period due to the absence of any previous descriptive studies at LifeFlight. The sample size of 100 is a conservative estimate based partly on a 2014 study at RFDS,Queensland (Le Cong et al A Ketamine Protocol and Intubation Rates for Psychiatric Air Medical Retrieval
Air Medical Journal ). Rather, the investigators plan to identify all the relevant participants during the study period and analyse the data to generate hypotheses which can then be tested in a prospective study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2016
Actual
Date of last participant enrolment
Anticipated
18/11/2016
Actual
Date of last data collection
Anticipated
30/11/2016
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294366 0
Self funded/Unfunded
Name [1] 294366 0
Vinay Gangathimmaiah
Country [1] 294366 0
Australia
Primary sponsor type
Individual
Name
Vinay Gangathimmaiah
Address
Lifeflight Australia, Townsville Base, Hangar 5, Avro Drive,Garbutt Queensland 4811
Country
Australia
Secondary sponsor category [1] 293209 0
None
Name [1] 293209 0
Address [1] 293209 0
Country [1] 293209 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295782 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 295782 0
1/538 Flinders Street,Townsville city, QLD 4810
Ethics committee country [1] 295782 0
Australia
Date submitted for ethics approval [1] 295782 0
05/07/2016
Approval date [1] 295782 0
26/07/2016
Ethics approval number [1] 295782 0
H16/07-200

Summary
Brief summary
Acute behavioural disturbance(ABD), also known as Excited Delirium Syndrome(ExDS), is a medical emergency with reported mortality of 8-10%.. The management of ABD usually necessitates a judicious combination of de-escalation techniques, physical restraints and sedation. Sedation of patients with ABD is usually accomplished with benzodiazepines and antipsychotics, either alone or in combination. The use of these two drug classes can be limited by several factors, primarily respiratory depression with benzodiazepines and a delayed onset of action of up to 20min with antipsychotics. In recent years, several small studies have explored the suitability of ketamine as an alternative agent for sedating patients with ABD in the prehospital, retrieval and emergency settings. Favourable pharmacological properties including rapid onset of action of 2-5min, protection of airway reflexes and maintenance of respiratory drive make ketamine a promising sedative agent in the management of ABD. Nevertheless insufficient data about effectiveness and safety of ketamine in the setting of ABD have prevented it from gaining widespread acceptance for this indication. Firstly, the effectiveness of ketamine sedation in ABD, as measured by sedation failure rates, has varied between no failures in one retrospective study and 10% in a recent prospective study. Furthermore, the reported incidence of endotracheal intubations with ketamine has also varied widely between studies, from no intubations to 39% . Interestingly, a large study looking at the incidence of intubations before and after introduction of a ketamine sedation protocol for ABD found a decrease in incidence from 3.5% to 2.3% while a smaller study using a combination of sedatives including ketamine also reported an intubation rate of 3%. Finally, there is a lack of clarity about the minimum effective ketamine dose needed to achieve safe sedation of behaviorally disturbed patients with reported dose ranges of 0.5-1mg/kg as the initial intravenous dose followed by 1 - 5.56mg/kg/h intravenous infusion and 2.25- 9.42mg/kg as the total intramuscular dose.

Along with benzodiazepines and antipsychotics, ketamine has been a part of the Standard Operating Procedure(SOP) for management of ABD at Lifeflight Retrieval Medicine( previously known as Careflight Retrieval Medicine, Queensland),Australia for over 3 years and Royal Flying Doctor Service(RFDS), Queensland, Australia for over 9 years. We want to examine the experience at these organizations to address our research question of whether ketamine is a safe and effective alternative agent for sedation of patients with acute behavioural disturbance in the aeromedical retrieval setting. Our study hypothesis is that in our aeromedical retrieval setting ketamine reduces the incidence of intubations in patients needing sedation for acute behavioural disturbance compared to the reported incidence of intubations in existing literature.
Trial website
Trial related presentations / publications
Public notes
Study recruitment sites:
1.LifeFlight,Queensland.
2.Royal Flight Doctor Service,Queensland.
Attachments [1] 1050 1050 0 0
/AnzctrAttachments/371353-KIA Data Abstraction Procedures and Coding Manual Version 2.0.docx (Supplementary information)
Attachments [2] 1052 1052 0 0
/AnzctrAttachments/371353-KIA Study Data Abstraction form Version 2.0.docx (Supplementary information)
Attachments [3] 1053 1053 0 0
/AnzctrAttachments/371353-Maguire_H1607-200_Low Risk Approved.pdf (Ethics approval)
Attachments [4] 1200 1200 0 0
/AnzctrAttachments/371353(v25-10-2016-17-34-53)-KIA protocol version 2.0.docx

Contacts
Principal investigator
Name 68470 0
Dr Vinay Gangathimmaiah
Address 68470 0
LifeFlight Australia, Hangar 5,Avro Drive, Garbutt, Queensland 4814
Country 68470 0
Australia
Phone 68470 0
+61432650840
Fax 68470 0
Email 68470 0
[email protected]
Contact person for public queries
Name 68471 0
Vinay Gangathimmaiah
Address 68471 0
LifeFlight Australia,Hangar 5,Avro Drive, Garbutt, Queensland 4814
Country 68471 0
Australia
Phone 68471 0
+61432650840
Fax 68471 0
Email 68471 0
[email protected]
Contact person for scientific queries
Name 68472 0
Vinay Gangathimmaiah
Address 68472 0
LifeFlight Australia,Hangar 5,Avro Drive, Garbutt, Queensland 4814
Country 68472 0
Australia
Phone 68472 0
+61432650840
Fax 68472 0
Email 68472 0
[email protected]

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